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The patent at issue is directed to compositions comprising stable nucleic acid-lipid particles ("SNALP") that have a non-lamellar morphology. Slip Op. at 2-3. Whether SNALP particles adopt a lamellar or non-lamellar morphology depends on both the lipids used for making the formulations, and the process used for forming SNALP particles. Id. The patent identifies five formulations (i.e., formulations using conjugated lipid and cationic lipid in molar ratios of 1:62, 1:57, 2:40, 2:30, and 10:15) that can be prepared by either Stepwise Dilution Method ("SDM") or Direct Dilution Method ("DDM"). Id. at 3-4. The patent further incorporates by reference each of two published patent applications (the '031 and '025 publications) "in its entirety for all purposes," including for disclosing the SDM and DDM methods. Id. at 4.

The Federal Circuit first addressed whether substantial evidence supports the Board's determination that the morphology limitation is inherently anticipated by the disclosure of the prior art patent, and found that it is. Id. at 12. The Federal Circuit conducted its analysis in three steps. First, it found that identical lipid compositions for the 1:57 and 1:62 formulations are disclosed in both the patent at issue and the prior art patent with the same level of specificity. Id. at 9-10. On this record, the Federal Circuit concluded that substantial evidence supports the Board's finding that the formulations are the same or essentially the same across the patents. Id. at 10. Second, the Federal Circuit found that while the patent at issue provides additional details that are not included in the prior art patent, both patents refer to, and incorporate by reference, the disclosure of the '031 publication for disclosing the processes and apparatuses for carrying out the DDM method. Id. at 10. The Federal Circuit concluded that the prior art patent discloses and describes DDM the same way as the patent at issue. Id. at 10-11. Third, the Federal Circuit concluded that because the Board did not err in finding that the prior art patent teaches the same formulations and the same DDM method as the patent at issue, the Board did not err in finding that such patent inherently anticipated the morphology limitation. Id. at 11-12.  Rejecting Arbutus' arguments, including that DDM is not a particular process but a broad genus of methods (id. at 9-10), the Federal Circuit stated that "[t]o anticipate, the prior art need only meet the inherently disclosed limitation to the same extent as the patented invention." Id. at 12. The Federal Circuit also rejected Arbutus' argument that this is a case where there is only a probability that the morphology limitation would result from controlling several variations of formulations and processes. Id. Instead, the Federal Circuit determined that this is a case where there are a "limited number of tools," i.e., five formulations and two processes, that a person skilled in the art would have to follow, and it was reasonable for the Board to find that such person would follow these disclosures resulting in a composition with the inherent morphological property. Id.